On December 6, 2021 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based immunotherapies, reported clinical data on its anti-CTLA-4 monoclonal antibody, ADG116, and anti-CD137 agonist, ADG106, in two poster presentations at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress 2021, to be held virtually and in Geneva, Switzerland from December 8 to 11, 2021 (Press release, Adagene, DEC 6, 2021, View Source [SID1234596494]). Both posters are available in the Publications section of the company’s website at www.adagene.com.

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In the first presentation of results from an ongoing dose-escalation trial of monotherapy in patients with advanced metastatic tumors, ADG116 demonstrated a strong safety profile and early signals of efficacy, including dose-dependent T-cell activation and tumor suppression in treatment-resistant "cold" and "warm" tumors such as pancreatic, ovarian and renal cell cancers.

Commenting on the findings, Dr. Gary Richardson, OAM, MBBS, FRACP, Group Director at Cabrini Health Research, Director at Szalmuk Family Department of Medical Oncology and Professor of Medicine at Monash University, Australia, "These encouraging clinical data demonstrate the promising safety profile of ADG116 monotherapy in patients with advanced solid tumors across 15 different tumor types, the majority of which are resistant to standard therapy. The most exciting thing about these results is that we have also seen the early signals of efficacy in ‘cold’ tumors such as pancreatic and certain gynecological cancers, which do not respond to current immunotherapies. We want to see this type of unique activity, which suggests that this treatment may look different and potentially better than the options we have available today."

Additionally, a separate poster presentation describing results of pharmacodynamic (PD) biomarker analyses reinforced the synergy and strong T-cell activation of ADG106 in combination with the anti-PD-1 antibody toripalimab.

A summary of data from both posters is included below.

ADG116

Key findings from the poster (#137P) titled "Phase 1 dose-finding study of a novel anti–CTLA-4 antibody ADG116 as monotherapy in patients with advanced solid tumors" include:

Clinical results from a global dose escalation and cohort expansion trial with sites in the U.S. and Australia (ADG116-1003) evaluated ADG116 monotherapy in 25 heavily pre-treated patients with advanced metastatic solid tumors, the majority of which are insensitive to immunotherapy:
Patients across 15 different tumor types were evaluated.
The majority (68 percent) received three or more lines of prior systemic therapy.
Nearly one quarter (24 percent) received prior immunotherapy treatment.
ADG116 monotherapy was well-tolerated up to 6 mg/kg with only Grade 1 or 2 treatment-related adverse events (TRAEs) observed; rash (20 percent) and pruritus (20 percent) were the most common.
In the ongoing 10 mg/kg cohort, a rash (Grade 3) and dose limiting toxicity event (Grade 4 hyperglycemia) occurred in a patient with renal cell carcinoma who relapsed on nivolumab. A significant increase in the patient’s CD8 T cells after one cycle of treatment showed that ADG116 is highly active for triggering T cell activation.
ADG116 treatment resulted in dose-dependent increases in peripheral CD8 and CD4 T cells, indicating immune activation by targeting the CTLA-4 pathway, starting at a dose as low as 0.03 mg/kg and becoming more striking at the 6 mg/kg and 10 mg/kg dose levels. In one example, a patient refractory to multiple cycles of pembrolizumab treated at 0.03 mg/kg showed increased CD8 and CD4 T cells.
In the dose escalation portion of the trial, four prolonged stable diseases were observed amongst these heavily pre-treated patients.
Of special note is a 22 percent tumor reduction observed in target lesions (after the data cut-off on October 15, 2021) following two cycles of ADG116 for a pancreatic cancer patient treated at 10 mg/kg. Only Grade 1 TRAEs were observed and the patient’s non-target lesion (23 x 12mm) disappeared. The patient continues on treatment.
Additionally, an ovarian cancer patient treated at 6mg/kg showed stable disease for more than 116 days with increased CD8 and CD4 T cells. The patient continues on treatment.
ADG116 demonstrated dose-proportional increases in drug exposure with a half-life supporting convenient dosing every three weeks.
The findings support that ADG116 has achieved the recommended dosing range as a single agent and for evaluation in combination therapy. The ADG116-1003 trial continues with dose escalation at 10 mg/kg, while cohort expansion has been initiated at 6 mg/kg.

Adagene is also advancing ADG116 in combination with anti-PD-1 therapy (pembrolizumab or toripalimab) and with its proprietary anti-CD137 agonist (ADG106). Further, the company is evaluating a second anti-CTLA-4 antibody, ADG126, using its SAFEbody precision masking technology in an ongoing phase 1 dose escalation as monotherapy. This reflects the company’s commitment to unlock the value of CTLA-4 as a proven target and the backbone of future immunotherapies.

ADG106

Key findings from the poster (#43P) titled "Assessment of Biomarker Kinetics for ADG106 (anti-CD137 agonist) as monotherapy or combined with toripalimab" include:

Results of PD biomarker analyses which demonstrated the synergistic effect of ADG106 in combination with an anti-PD-1 antibody, toripalimab, compared to ADG106 monotherapy at doses up to 3 mg/kg.
The combination of ADG106 with toripalimab resulted in a 2-fold greater immune activation versus ADG106 alone. These results were observed even amongst patients who failed prior anti-PD-1 and CTLA-4 therapies.
Soluble CD137 levels (sCD137) levels increased with immune activation suggesting this as a dose-dependent PD biomarker of T cell target engagement, which could be used to monitor potential clinical response.
ADG106 treatment alone and in combination with anti-PD-1 therapy also increased serum IFN-γ, IL-6, natural killer cells, and T-cell subsets.
Additional analyses demonstrate that the pharmacokinetic profile of ADG106 was not altered by the addition of toripalimab.
These findings highlight the synergistic activity of ADG106 in combination with the anti-PD-1 toripalimab for patients who failed anti-PD-1 and anti-CTLA-4 immunotherapies. This combination is being evaluated in the ongoing ADG106-1008 clinical trial, currently in a cohort dosing ADG106 at 3 mg/kg. The data support further exploration of combination therapy regimens with ADG106 at informed dose ranges for targeting biomarker enriched tumor types.

"The data presented today from two of our NEObody clinical programs show how we are creating transformative antibody-based immunotherapies that push the limits of antibody discovery and development, overcoming liabilities with some of the most promising yet challenging immuno-oncology targets today," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "These findings strengthen confidence in our clinical pipeline and in the ability of our platform technologies to achieve unprecedented results that will ultimately benefit patient care."

About ADG116

This NEObody program, targeting a unique epitope of CTLA-4, is being evaluated in patients with advanced/metastatic solid tumors. ADG116 is designed to enhance efficacy by potent Treg depletion in the tumor microenvironment (TME) and maintain its physiological function by soft ligand blocking to address safety concerns associated with existing CTLA-4 therapeutics.

About ADG106

This NEObody program is a fully human ligand-blocking, agonistic anti-CD137 IgG4 monoclonal antibody (mAb) that is being evaluated in patients with advanced solid tumors and/or non-Hodgkin’s lymphoma.

On December 6, 2021 Novocure (NASDAQ: NVCR) reported the 4th Annual AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research Program. The program represents a joint effort with the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to promote and support innovative research on Tumor Treating Fields (TTFields) to help deepen the understanding of the mechanism of action and to accelerate the development of new treatment strategies (Press release, NovoCure, DEC 6, 2021, View Source [SID1234596510]). The program includes research grants and career development awards totaling more than $2 million over the next three years.

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The research grants will include five AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants and two AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research. Recipients of the research grants will receive a total of $250,000 over two years. Recipients of the career development awards will receive a total of $225,000 over three years.

"We are thrilled to continue our partnership with Novocure," said Mitch Stoller, the AACR (Free AACR Whitepaper)’s Chief Philanthropic Officer. "These two grant mechanisms represent an important means for advancing the science of TTFields research and attracting talented investigators. We once again look forward to learning about the outstanding projects that will result from these grants and to meeting next year’s class of grantees."

Novocure and the AACR (Free AACR Whitepaper) encourage applicants to focus their proposals on translational approaches, promoting the transition of in vitro work into in vivo systems; combination therapies involving Tumor Treating Fields; and bringing treatments involving Tumor Treating Fields to the clinic. The application deadline is January 20. Recipients will be announced in April at the AACR (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans.

"Deepening our understanding of the mechanism of action of Tumor Treating Fields can potentially advance our efforts to extend survival in some of the most aggressive forms of cancer," said Dr. Uri Weinberg, Novocure’s Chief Science Officer. "We are excited to partner with the AACR (Free AACR Whitepaper) to offer this innovative research program for the fourth year and look forward to the announcement of recipients at the AACR (Free AACR Whitepaper) Annual Meeting."

To apply for the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research, visit www.aacr.org/funding.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research on TTFields extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields therapy.

On December 6, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets in cancer and autoimmune disease, and Cancer Research UK, the world’s leading cancer charity, reported that the first patient has been dosed in a Phase 1 clinical trial of HMBD-001 for the treatment of patients with advanced HER3-expressing solid malignancies (NCT05057013) (Press release, Hummingbird Bioscience, DEC 6, 2021, View Source [SID1234596530]).

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The Phase 1 clinical trial in the United Kingdom is being sponsored and managed by Cancer Research UK’s Centre for Drug Development and led by Chief Investigator, Professor Johann De Bono at the Royal Marsden Hospital and The Institute of Cancer Research, London. The trial intends to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and explore preliminary evidence of HMBD-001 activity in patients with advanced HER3-expressing solid malignancies, including NRG1 fusion-driven cancers.

HMBD-001 is the first of Hummingbird Bioscience’s deep pipeline of antibody drug candidates to enter clinical trials. Rationally developed using Hummingbird Bioscience’s proprietary Rational Antibody Discovery (RAD) platform, HMBD-001 is the only reported anti-HER3 antibody in clinical development that uses a highly differentiated mechanism of action designed to block the formation of all active HER3 dimers, regardless of NRG1 ligand binding or HER2/EGFR overexpression.

"Dosing of the first patient in the clinical trial of HMBD-001, Hummingbird’s most advanced program, marks the beginning of a potentially transformative approach to treating HER3-driven cancers," said Dr. Jerome Boyd-Kirkup, Chief Scientific Officer, Hummingbird Bioscience. "I am immensely proud of the teamwork that has brought our differentiated program to this point. Hummingbird Bioscience is dedicated to discovering and developing important medicines for cancer and autoimmune disease with our unique Rational Antibody Discovery platform."

"This significant milestone brings us a step closer to provide a much-needed and highly differentiated therapy for patients with HER3-driven cancers," said Dr. Eric Rowinsky, Chief Medical Officer, Hummingbird Bioscience. "We are pleased to partner with Cancer Research UK for this trial, and we look forward to advancing the clinical development of HMBD-001 for cancer patients."

Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, said, "We are thrilled to be working with Hummingbird Bioscience to advance its novel drug candidate into clinical trials. Although HER3 was discovered over 30 years ago, no therapies able to block its cancer-promoting action have been approved. Hummingbird Bioscience has taken fresh aim at a difficult drug target and has come up with a novel, potentially transformative antibody for cancer patients who desperately need new treatments."

Initial data from the Phase 1 dose escalation is expected in the second half of 2022.

About HMBD-001

HMBD-001 is a clinical-stage IgG1 antibody designed to target HER3. Discovered using our proprietary RAD platform, HMBD-001 is now in development for the treatment of multiple solid tumors. We believe HMBD-001 is the only anti-HER3 antibody in development that has the potential to fully block both ligand-dependent and independent HER3 activation and oncogenic signaling, by targeting a key epitope located at the interface where HER3 forms heterodimers with HER2 or EGFR, independent of the process leading to such dimerization. In preclinical models evaluating HMBD-001, we have observed superior affinity and more potently inhibited tumor growth compared to other existing anti-HER3 antibodies. Our near-term development plan for HMBD-001 focuses on four priority, high-value indications with strong scientific rationale and supporting preclinical data: NRG1 fusion-driven cancers, metastatic castrate resistant prostate cancer (mCRPC), metastatic colorectal cancer (mCRC), and squamous cell carcinoma of the head and neck (SCCHN).

On December 6, 2021 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported that it has entered into a third clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), through a subsidiary (Press release, IO Biotech, DEC 6, 2021, View Source [SID1234596479]). The purpose of the collaboration is to evaluate IO Biotech’s lead candidate, IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in previously untreated patients with three different tumor types— metastatic non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and metastatic urothelial bladder cancer (UBC). IO102-IO103 is an investigational novel immunotherapeutic agent designed to target the mechanisms mediated by key immunosuppressive proteins such as Indoleamine 2,3-dehydrogenase (IDO) and PD-L1.

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"We are pleased to be collaborating once again with Merck to study the potential of our IDO and PD-L1 derived immune-modulating therapy in combination with pembrolizumab as part of our broad, late-stage development program," said Mai-Britt Zocca, PhD, CEO and founder of IO Biotech. "We believe IO102-IO103 has the potential to show utility for multiple cancer indications, and we look forward to expanding our dataset in these additional settings."

The planned Phase 2 trial will evaluate the safety and efficacy of the combination of IO102-IO103 with pembrolizumab in patients with previously untreated metastatic NSCLC, SCCHN, or UBC. Additional correlative endpoints will also be explored to elucidate the mechanism of action. Under the terms of the agreement, IO Biotech will sponsor the Phase 2 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IO102-IO103/IOB-022

Based on the results from a Phase 1/2 clinical trial, IO102-IO103, in combination with pembrolizumab, was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for treatment of unresectable/metastatic melanoma. IO Biotech plans to initiate a Phase 3 combination trial of IO102-IO103 and KEYTRUDA (pembrolizumab), as first-line treatment in metastatic melanoma patients which is designed to be potentially registrational for IO102-IO103.

On December 6, 2021 Adicet Bio, Inc. (Nasdaq: ACET), a biotechnology company discovering and developing first-in-class allogeneic gamma delta CAR T cell therapies for cancer and other diseases, reported positive interim data from its dose escalation Phase 1 study evaluating the safety and tolerability of ADI-001, Adicet’s investigational therapy targeting CD20 for the potential treatment of B-cell Non-Hodgkin’s Lymphoma (Press release, Adicet Bio, DEC 6, 2021, View Source [SID1234596495]).

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As of the November 22, 2021 data cutoff, six patients had been enrolled and received ADI-001. The first two patients enrolled in the lowest dose level tested did not reach the day 28 assessment and were not evaluable for efficacy per protocol. Three of the four evaluable patients achieved responses, including two complete responses (CR) and one partial response (PR) that investigators characterized as near complete response. Patients were heavily pre-treated, with a median of five lines of prior systemic therapy, including a patient who had received prior autologous CD19 CAR T,​ and achieved complete response following a single infusion of ADI-001 administered at the lowest dose level.

"We are extremely excited to see such profound early complete responses in our Phase 1 dose-finding study evaluating ADI-001 as monotherapy among patients with very advanced cancer starting at our first dose level of 30 million CAR+ cells," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "Data to-date suggest that ADI-001 is highly clinically active. We look forward to reporting additional data in the first half of 2022 and to rapidly progressing our pipeline to realize the full potential of our gamma delta CAR T cell platform for patients."

"The unequivocal responses to ADI-001 in this heavily pre-treated patient population at such low dose levels are highly promising," said Sattva Neelapu M.D., Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. "These data suggest that ADI-001 has the potential to be an effective treatment option for B cell malignancies if confirmed in further clinical testing. ADI-001 does not require gene editing and provides complementary innate, adaptive, and CAR mediated antitumor effects which may improve durability and minimize emergence of tumor resistance."

Of the four efficacy evaluable patients, three received ADI-001 at dose level one (30 million CAR+ cells) and one received ADI-001 at dose level two (100 million CAR+ cells). In dose level one, one patient achieved a CR, one patient achieved a PR that was characterized as near CR and one patient had progressive disease (PD). In dose level two, the first patient achieved a CR.

All evaluable patients had been heavily pre-treated with a median of five lines of prior systemic therapies. Of the three patients who achieved PR or better under Lugano 2014 criteria (ORR=75%, CR=50%), one had diffuse large B-cell lymphoma (DLBCL) with five prior lines of therapy including two cycles of anti-CD19 CAR T cell therapy, one had follicular lymphoma transformed into a large B-cell tumor with four prior lines of therapy, and the third had mantle cell lymphoma with five prior lines of therapy. These patients achieved two CRs and a near CR.

Overall, ADI-001 infusions were generally well-tolerated. No dose-limiting toxicities, graft vs host disease (GvHD), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) or grade 3 or higher Cytokine Release Syndrome (CRS) have been reported to-date, suggesting a potentially wide therapeutic window for ADI-001.

A significant increase in circulating IL-15 was observed during the 28-day window following lymphodepletion, potentially providing cytokine support for the proliferation of ADI-001​. Emergence of circulating ADI-001 in the blood was observed by quantitative polymerase chain reaction and by flow cytometry, demonstrating expansion of ADI-001 in patients​. Elevations in additional circulating cytokines, primarily IL-2 and IL-8 were observed during the first 14 days from dosing, consistent with the activation profile of ADI-001 and similar to the observed time-to-peak for cytokines previously reported in association with autologous alpha-beta CAR T cells. Importantly, no meaningful increases in IL-6 were seen in association with ADI-001, except for one patient who experienced COVID-19 infection, suggesting reduced likelihood for ICANS and high-grade CRS.

"It is remarkable to see our early preclinical studies translate to the clinic. The preliminary safety and efficacy data from low-dose ADI-001 collected to date indicate the potential for a broad therapeutic window. Without the need for gene editing and its associated safety concerns, our platform is designed to preserve the natural innate and adaptive anti-tumor activity of gamma delta CAR T cells, which we believe may lead to better durability," said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio. "As we look to expand into additional cohorts, we plan to leverage our scalable off-the-shelf manufacturing process to meet future needs. We look forward to advancing our novel allogeneic gamma delta T cell pipeline for cancer patients."

Table 1: Summary of ADI-001 interim data from two dosing cohorts*:

Dose Level Age/Sex B-cell lymphoma subtypes # Prior lines of therapies Prior CAR T? Best Response (BOR) by Lugano Criteria (2014)
30 million CAR+ cells

62/F Transformed DLBCL​
(from chronic lymphocytic leukemia) 5 prior lines No PD
66/F Transformed high grade​
B cell tumor (from follicular lymphoma) 4 prior lines

No PR
(Near CR)
75M DLBCL 5 prior lines Yes (liso-cel) CR
100 million CAR+ cells 62/M Mantle cell lymphoma 5 prior lines No CR
*Efficacy evaluable patients as of November 22, 2021 database entry. Data are subject to further review and verification.

Webcast/Conference Call Information
Adicet will host a live presentation on Monday, December 6 at 8:30am EST to discuss the results. Dr. Sattva Neelapu from the University of Texas MD Anderson Cancer Center will participate in the event.

The live webcast of the presentation can be accessed under "Presentations & Events" in the investors section of the Company’s website at www.adicetbio.com or by dialing (877) 800-3802 (domestic) or (615) 622-8057 (international) and reference the conference ID 6952318. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About ADI-001
ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy being developed as a treatment for B-cell non-Hodgkin’s lymphoma. ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent antitumor activity in preclinical models, leading to long-term control of tumor growth.

About the GLEAN Study
This Phase I study is an open-label, multi-center study of ADI-001 enrolling adults diagnosed with B cell malignancies who have either relapsed, or are refractory to at least two prior regimens. The primary objectives of the study are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ADI-001, and to determine optimal dosing as a monotherapy. The study is expected to enroll approximately 75 patients. For more information about the clinical study design, please visit: www.clinicaltrials.gov (NCT04735471).